iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

NCT06244979 | Recruiting Phase 2

• 2 other identifiers: 1151362023-509744-10-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of \[68Ga\]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection. The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like \[68Ga\]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, \[68Ga\]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.

Conditions

Pulmonary Aspergillosis; Chronic Pulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis

Outcome Measures

Primary Outcomes (2)

• Standardized uptake values (SUV) of [68Ga]Ga-DFO-B

  Measurement of the amount of radiotracer uptake (\[68Ga\]Ga-DFO-B) in suspected Aspergillus lesions in patients with pulmonary aspergillosis.

  PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B

• Target-to-background ratios of [68Ga]Ga-DFO-B

  Ratio of the signal intensity or uptake in suspected Aspergillus lesions (target) to the background signal intensity in the surrounding normal tissues in patients with pulmonary aspergillosis.

  PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will undergo a PET/CT scan at t=60 min after a single intravenous injection of a fixed dose of 100 MBq +/- 10% \[68Ga\]Ga-DFO-B (gallium-68-deferoxamine) which contains 100 µg deferoxamine (DFO-B).

Other: Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)

Interventions

Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) OTHER

100 MBq +/- 10% \[68Ga\]Ga-DFO-B which contains 100 µg DFO-B (see description in arm description)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has suspected chronic pulmonary aspergillosis or ABPA.
• There is no significant interference with standard care and follow-up.

You may not qualify if:

• The patient is pregnant or planning on becoming pregnant.
• The patient has severe kidney dysfunction with eGFR \< 30 ml/min/kg and/or receives dialysis.
• The patient has (chronic) iron overload.
• The patient has been receiving antifungal treatment for more than 48 hours prior to the study day.
• The patient is not able to lie still in the scanner.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

RadboudUMC

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Roger Brüggemann, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Michon

CONTACT

024 361 1111; laura.michon@radboudumc.nl

Roger Brüggemann

CONTACT

024 361 1111; roger.bruggemann@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 6, 2024
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)